RESUMEN
Spanish Autonomous Communities (ACs) are entitled to decide on the prescription requirements of their own territories, which can create inequalities in access to new drugs in the management of psoriasis. The objective of this study was to assess whether the level of restrictions in the access to new drugs for the management psoriasis was associated with the probability of achieving disease control measured using the Minimum Disease Activity (MDA) criteria. Therefore, we combined the results of 2 previous independent, cross-sectional studies: one that described the MDA in psoriasis by AC, and another that evaluated the level of restrictions to drug access by AC. We found that the higher the number of restrictions the lower the chances of achieving the MDA criteria (P=.013). Our results suggest that, in Spain, geographical differences in the access to new drugs may be creating health inequalities across the country.
RESUMEN
INTRODUCTION: In 2017, the Spanish Academy of Dermatology and Venereology Psoriasis Working Group (PWG) designed the Minimal Disease Activity (MDA) criteria to determine the level of disease activity. We hereby present the results of an observational, cross-sectional, multicenter study of the nationwide application of these criteria. MATERIAL AND METHODS: We conducted a non-randomized sampling, stratified to achieve autonomic and provincial representation of consecutive patients with psoriasis (Ps) vulgaris without active arthritis. A total of 830 patients were included: 493 men (59.5%), with a mean age of 51.4 years (SD, 14.2), from all autonomous regions of Spain (except for Ceuta and Melilla) and 44 (88%) out of the 50 provinces. A questionnaire was obtained with demographic data, DLQI, subjective assessment-on a scale from 0 to 10-of itching, erythema, desquamation, visibility, and the patients' PASI and BSA. RESULTS: More than 50% failed to meet the MDA criteria (491; 59.2%), with significant differences being reported by region, sex, and age. Additionally, significant differences were reported based on the therapy used (P<.001). The use of biological therapies was associated with higher MDA compliance compared to other therapies (59.4% vs 23.3%). No differences were reported among various biological therapies. CONCLUSIONS: The overall rate of MDA compliance is low, with differences being based on geographic location, sex, age, and drug used, yet none of these factors separately justify them.
RESUMEN
Spanish Autonomous Communities (ACs) are entitled to decide on the prescription requirements of their own territories, which can create inequalities in access to new drugs in the management of psoriasis. The objective of this study was to assess whether the level of restrictions in the access to new drugs for the management psoriasis was associated with the probability of achieving disease control measured using the Minimum Disease Activity (MDA) criteria. Therefore, we combined the results of 2 previous independent, cross-sectional studies: one that described the MDA in psoriasis by AC, and another that evaluated the level of restrictions to drug access by AC. We found that the higher the number of restrictions the lower the chances of achieving the MDA criteria (P=.013). Our results suggest that, in Spain, geographical differences in the access to new drugs may be creating health inequalities across the country.
RESUMEN
Antecedentes: En España, aunque el Ministerio de Sanidad elabora el informe de posicionamiento terapéutico (IPT) y las condiciones de reembolso de los fármacos, las Comunidades Autónomas (CC. AA.) gestionan los servicios de salud y deciden sobre las condiciones de prescripción en su ámbito territorial. El objetivo del estudio EQUIDAD fue describir los condicionantes para la prescripción de los nuevos fármacos en Dermatología en las CC. AA. y sus posibles diferencias. Material y métodos: Estudio transversal realizado en abril-mayo del 2023. Dos dermatólogos con responsabilidades directivas de cada Comunidad Autónoma (C. A.) informaron sobre los condicionantes autonómicos y locales en la prescripción de los fármacos cuyo IPT para el tratamiento de enfermedades dermatológicas fue publicado en los años 2016-2022. Los datos fueron recogidos mediante un cuestionario online. Resultados: Un total de 33 investigadores de 17 CC. AA. participaron en el estudio. Se observaron inequidades entre CC. AA. para el acceso a los nuevos fármacos. Existieron condicionantes autonómicos adicionales al IPT en psoriasis en el 64,7% de las CC. AA., siendo este porcentaje menor en dermatitis atópica (35,3%) o melanoma (11,8%). El más frecuente fue el requisito de un orden de prescripción previo para el uso del fármaco. En algunas CC. AA. se detectaron además variaciones y condicionantes locales (diferencias entre centros de una misma C. A.). Conclusiones: Existe una multiplicidad de criterios tanto a nivel autonómico como local que añade restricciones adicionales a las establecidas por los IPT y que plantean una situación de inequidad entre los pacientes y los profesionales de las diferentes CC. AA. en el acceso a los nuevos fármacos. (AU)
Background: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. Material and methods: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. Results: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). Conclusions: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain. (AU)
Asunto(s)
Humanos , Equidad , Preparaciones Farmacéuticas , Psoriasis , Dermatitis Atópica , Oncología Médica , Dermatólogos , España , Estudios TransversalesRESUMEN
Background: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. Material and methods: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. Results: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). Conclusions: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain. (AU)
Antecedentes: En España, aunque el Ministerio de Sanidad elabora el informe de posicionamiento terapéutico (IPT) y las condiciones de reembolso de los fármacos, las Comunidades Autónomas (CC. AA.) gestionan los servicios de salud y deciden sobre las condiciones de prescripción en su ámbito territorial. El objetivo del estudio EQUIDAD fue describir los condicionantes para la prescripción de los nuevos fármacos en Dermatología en las CC. AA. y sus posibles diferencias. Material y métodos: Estudio transversal realizado en abril-mayo del 2023. Dos dermatólogos con responsabilidades directivas de cada Comunidad Autónoma (C. A.) informaron sobre los condicionantes autonómicos y locales en la prescripción de los fármacos cuyo IPT para el tratamiento de enfermedades dermatológicas fue publicado en los años 2016-2022. Los datos fueron recogidos mediante un cuestionario online. Resultados: Un total de 33 investigadores de 17 CC. AA. participaron en el estudio. Se observaron inequidades entre CC. AA. para el acceso a los nuevos fármacos. Existieron condicionantes autonómicos adicionales al IPT en psoriasis en el 64,7% de las CC. AA., siendo este porcentaje menor en dermatitis atópica (35,3%) o melanoma (11,8%). El más frecuente fue el requisito de un orden de prescripción previo para el uso del fármaco. En algunas CC. AA. se detectaron además variaciones y condicionantes locales (diferencias entre centros de una misma C. A.). Conclusiones: Existe una multiplicidad de criterios tanto a nivel autonómico como local que añade restricciones adicionales a las establecidas por los IPT y que plantean una situación de inequidad entre los pacientes y los profesionales de las diferentes CC. AA. en el acceso a los nuevos fármacos. (AU)
Asunto(s)
Humanos , Equidad , Preparaciones Farmacéuticas , Psoriasis , Dermatitis Atópica , Oncología Médica , Dermatólogos , España , Estudios TransversalesRESUMEN
BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.
Asunto(s)
Dermatología , Humanos , España , Estudios TransversalesRESUMEN
BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.
Asunto(s)
Dermatología , Humanos , España , Estudios TransversalesRESUMEN
BACKGROUND: In recent years, remarkable improvements in our understanding of atopic dermatitis (AD) have revolutionized treatment perspectives, but access to reliable data from clinical practice is essential. MATERIALS AND METHOD: The Spanish Atopic Dermatitis Registry, BIOBADATOP, is a prospective, multicenter database that collects information on patients of all ages with AD requiring systemic therapy with conventional or novel drugs. We analyzed the registry to describe patient characteristics, diagnoses, treatments, and adverse events (AEs). RESULTS: We studied data entries for 258 patients who had received 347 systemic treatments for AD. Treatment was discontinued in 29.4% of cases, mostly due to a lack of effectiveness (in 10.7% of cases). A total of 132 AEs were described during follow-up. Eighty-six AEs (65%) were linked to a systemic treatment, most commonly dupilumab (39AEs) and cyclosporine (38AEs). The most common AEs were conjunctivitis (11patients), headache (6), hypertrichosis (5), and nausea (4). There was 1severe AE (acute mastoiditis) associated with cyclosporine. CONCLUSIONS: Initial findings on AEs from the Spanish BIOBADATOP registry are limited by short follow-up times precluding comparisons or calculation of crude and adjusted incidence rates. At the time of our analysis, no severe AEs had been reported for novel systemic therapies. BIOBADATOP will help answer questions on the effectiveness and safety of conventional and novel systemic therapies in AD.
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Dermatitis Atópica , Humanos , Dermatitis Atópica/tratamiento farmacológico , Dermatitis Atópica/epidemiología , Estudios Prospectivos , Ciclosporina/uso terapéutico , Administración Cutánea , Sistema de Registros , Resultado del Tratamiento , Índice de Severidad de la EnfermedadRESUMEN
Sonidegib is an antagonist of the transmembrane protein Smoothened in the Hedgehog signaling pathway. It is indicated for the treatment of locally advanced basal cell carcinoma (BCC) that is not amenable to curative surgery or radiotherapy. Sonidegib's efficacy and safety were demonstrated in the phase 2 BOLT trial, where 61% (95% CI, 48-72%) of patients with locally advanced BCC treated with sonidegib 200 mg achieved an objective response to treatment with a mean time to response of 4 months. The median duration of response was 26.1 months and the median progression-free survival was 22.1 months. The most common adverse events were muscle spasms (54.4%), hair loss (49.4%), and loss of taste (44.3%); most events were grade 1 or 2. In this review, we summarize the main findings on the efficacy, safety, and tolerability of sonidegib and discuss the management of locally advanced BCC with this drug.
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Antineoplásicos , Carcinoma Basocelular , Neoplasias Cutáneas , Antineoplásicos/efectos adversos , Compuestos de Bifenilo , Carcinoma Basocelular/tratamiento farmacológico , Proteínas Hedgehog/uso terapéutico , Humanos , Piridinas , Neoplasias Cutáneas/tratamiento farmacológicoAsunto(s)
Varicela , Infecciones por Coronavirus , Pandemias , Neumonía Viral , Betacoronavirus , COVID-19 , Consenso , Humanos , Estudios Prospectivos , SARS-CoV-2 , EspañaRESUMEN
Drago et al. are right to point out that our paper did not provide data on enanthems.1,2 As the data collection form did not include the description of mucous membranes, they might not have been explored in many patients. We have reported and included in the supplementary material a few cases that were noticed by their doctors and were the first descriptions of enanthem in COVID-19. Given the low number of cases and their nonsystematic acquisition, we avoided any analysis of these data.
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Betacoronavirus , Infecciones por Coronavirus , Pandemias , Neumonía Viral , Enfermedades de la Piel , COVID-19 , Humanos , SARS-CoV-2RESUMEN
BACKGROUND: The cutaneous manifestations of COVID-19 disease are poorly characterized. OBJECTIVES: To describe the cutaneous manifestations of COVID-19 disease and to relate them to other clinical findings. METHODS: We carried out a nationwide case collection survey of images and clinical data. Using a consensus we described five clinical patterns. We later described the association of these patterns with patient demographics, the timing in relation to symptoms of the disease, the severity and the prognosis. RESULTS: The lesions may be classified as acral areas of erythema with vesicles or pustules (pseudo-chilblain) (19%), other vesicular eruptions (9%), urticarial lesions (19%), maculopapular eruptions (47%) and livedo or necrosis (6%). Vesicular eruptions appear early in the course of the disease (15% before other symptoms). The pseudo-chilblain pattern frequently appears late in the evolution of the COVID-19 disease (59% after other symptoms), while the rest tend to appear with other symptoms of COVID-19. The severity of COVID-19 shows a gradient from less severe disease in acral lesions to more severe in the latter groups. The results are similar for confirmed and suspected cases, in terms of both clinical and epidemiological findings. Alternative diagnoses are discussed but seem unlikely for the most specific patterns (pseudo-chilblain and vesicular). CONCLUSIONS: We provide a description of the cutaneous manifestations associated with COVID-19 infection. These may help clinicians approach patients with the disease and recognize cases presenting with few symptoms. What is already known about this topic? Previous descriptions of cutaneous manifestations of COVID-19 were case reports and mostly lacked illustrations. What does this study add? We describe a large, representative sample of patients with unexplained skin manifestations and a diagnosis of COVID-19, using a consensus method to define morphological patterns associated with COVID-19. We describe five clinical patterns associated with different patient demographics, timing and prognosis, and provide illustrations of these patterns to allow for easy recognition.
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Betacoronavirus/patogenicidad , Consenso , Infecciones por Coronavirus/complicaciones , Neumonía Viral/complicaciones , Enfermedades Cutáneas Virales/clasificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , COVID-19 , Niño , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/virología , Dermatólogos/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Neumonía Viral/virología , Pronóstico , Estudios Prospectivos , SARS-CoV-2 , Enfermedades Cutáneas Virales/diagnóstico , Enfermedades Cutáneas Virales/virología , España/epidemiología , Encuestas y Cuestionarios/estadística & datos numéricos , Terminología como Asunto , Factores de Tiempo , Adulto JovenAsunto(s)
Enfermedades Endémicas/estadística & datos numéricos , Genes MHC Clase II/genética , Pénfigo/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Técnicas de Genotipaje , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Pénfigo/diagnóstico , Pénfigo/genética , España/epidemiología , Adulto JovenRESUMEN
ANTECEDENTES Y OBJETIVOS: El impacto negativo que la psoriasis tiene en la calidad de vida del paciente puede ser tan importante como sus consecuencias físicas. Podríamos suponer que el blanqueamiento de la enfermedad conllevaría también una mejoría de su impacto psicosocial. El presente estudio valora el estado psicológico de los pacientes con psoriasis controlados con tratamiento sistémico en una Unidad de Psoriasis, especialmente en aquellos con una afectación leve o nula de la enfermedad. MÉTODOS: Estudio epidemiológico observacional y trasversal, sin intervención, con dos cohortes (casos y controles). Los pacientes autocompletaron datos demográficos y 4 cuestionarios (Cuestionario de autoestima de Rosenberg, Skindex-29, HADS y COPE-28) en una única visita. RESULTADOS: Se reclutaron 111 pacientes diagnosticados de psoriasis y 109 pacientes control. En autoestima, el promedio y la desviación estándar (DE) del grupo de psoriasis fue de 33,5 (4,8) y de 33,3 (6,7) para el grupo control, sin diferencias significativas. En el Skindex-29, la puntuación media del grupo de pacientes con psoriasis fue casi 3 veces mayor que la media del grupo control (30 vs. 11). Se encontraron diferencias significativas en las puntuaciones del HADS de ambos grupos (12,7 vs. 9,0; p < 0,001). Las puntuaciones promedio del HADS-A fueron de 8,0 (4,78) en el grupo de psoriasis frente a 5,7 (3,8) en el grupo control (p < 0,001), mientras que las del HADS-D fueron de 4,7 (3,9) frente a 3,2 (3,1) (p < 0,004), respectivamente. CONCLUSIONES: Los resultados obtenidos indican que es necesario medir el estado psicológico de nuestros pacientes con psoriasis, pues incluso con un control casi total de la enfermedad la afectación psicológica permanece
BACKGROUND AND OBJECTIVES: The negative impact of psoriasis on patient quality of life can be as important as the physical consequences of the disease. We could assume that clearance of the disease would also lead to an improvement in its psychosocial impact. The present study assesses the psychological state of patients with psoriasis receiving systemic treatment in a psoriasis unit, especially those with mild or no disease involvement. METHODS: We performed a cross-sectional, observational, noninterventional epidemiological study of 2 cohorts (cases and controls). The patients self-completed demographic data and 4 questionnaires (Rosenberg Self-Esteem Scale, Skindex-29, HADS, and COPE-28 questionnaire) at a single visit. RESULTS: We recruited 111 patients diagnosed with psoriasis and 109 control patients. In self-esteem, the mean and standard deviation (SD) score was 33.5 (4.8) for the psoriasis group and 33.3 (6.7) for the control group, with no significant differences. In the Skindex-29, the mean score for the psoriasis group was almost 3 times higher than that of the control group (30 vs. 11). Significant differences were found in the HADS scores of both groups (12.7 vs. 9.0, P<.001). The mean HADS-A scores were 8.0 (4.78) for the psoriasis group compared with 5.7 (3.8) for the control group (P<.001). In the case of HADS-D, the scores were 4.7 (3.9) compared with 3.2 (3.1) (P<.004), respectively. CONCLUSIONS: Our findings indicate that it is necessary to assess the psychological state of patients with psoriasis, because psychological effects persist even in cases where the disease is almost totally controlled
Asunto(s)
Humanos , Masculino , Femenino , Persona de Mediana Edad , Psoriasis/tratamiento farmacológico , Psoriasis/psicología , Autoimagen , Perfil de Impacto de Enfermedad , Calidad de Vida , Psoriasis/epidemiología , Estudios Transversales , Estudio Observacional , Encuestas y Cuestionarios , 28599 , Adaptación PsicológicaRESUMEN
INTRODUCCIÓN Y OBJETIVOS: La utilización clínica habitual de los fármacos biológicos en el tratamiento de la psoriasis es en segunda línea, es decir, tras el uso previo de un fármaco clásico. Sin embargo, en casos particulares -particularidades del paciente o criterio médico- se realiza la indicación en primera línea. No existen estudios sobre las características demográficas, clínicas y de seguridad de los pacientes que reciben fármaco biológico en primera línea. Como objetivo primario se pretende determinar dichas características de acuerdo con la iniciación de la terapia biológica en primera o segunda línea. MATERIAL Y MÉTODO: Se realizó un estudio descriptivo, multicéntrico, de 181 pacientes que iniciaron tratamiento biológico como primer fármaco sistémico para control de su psoriasis moderada-grave, y que forman parte del Registro Español de Acontecimientos Adversos Asociados con Medicamentos Biológicos en Dermatología, entre enero de 2008 y noviembre de 2016. RESULTADOS: Los pacientes de ambos grupos son muy similares, si bien se evidencia que el grupo que recibe el biológico en primera línea presenta una edad más avanzada, sin que se justifique por gravedad de la enfermedad (PASI) ni por el tiempo de evolución de esta desde el diagnóstico. En este grupo de pacientes es más frecuente la presencia de hipertensión, diabetes y hepatopatía. No hemos encontrado diferencias en motivos de suspensión ni seguridad entre ambos grupos. CONCLUSIONES: No se han encontrado diferencias relevantes entre los 2 grupos, lo cual refuerza la seguridad de los fármacos biológicos en este contexto
INTRODUCTION AND OBJECTIVES: Biologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy. MATERIAL AND METHOD: We conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology. RESULTS: The characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects. CONCLUSIONS: No major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis
Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Productos Biológicos/uso terapéutico , Inmunosupresores/uso terapéutico , Psoriasis/tratamiento farmacológico , Sistema de Registros , Anticuerpos Monoclonales/uso terapéutico , Distribución por Edad , Anticuerpos Monoclonales/efectos adversos , Productos Biológicos/efectos adversos , Comorbilidad , Sustitución de Medicamentos , Utilización de Medicamentos , Inmunosupresores/efectos adversos , Psoriasis/epidemiología , España/epidemiología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
BACKGROUND AND OBJECTIVES: The negative impact of psoriasis on patient quality of life can be as important as the physical consequences of the disease. We could assume that clearance of the disease would also lead to an improvement in its psychosocial impact. The present study assesses the psychological state of patients with psoriasis receiving systemic treatment in a psoriasis unit, especially those with mild or no disease involvement. METHODS: We performed a cross-sectional, observational, noninterventional epidemiological study of 2 cohorts (cases and controls). The patients self-completed demographic data and 4 questionnaires (Rosenberg Self-Esteem Scale, Skindex-29, HADS, and COPE-28 questionnaire) at a single visit. RESULTS: We recruited 111 patients diagnosed with psoriasis and 109 control patients. In self-esteem, the mean and standard deviation (SD) score was 33.5 (4.8) for the psoriasis group and 33.3 (6.7) for the control group, with no significant differences. In the Skindex-29, the mean score for the psoriasis group was almost 3 times higher than that of the control group (30 vs. 11). Significant differences were found in the HADS scores of both groups (12.7 vs. 9.0, P<.001). The mean HADS-A scores were 8.0 (4.78) for the psoriasis group compared with 5.7 (3.8) for the control group (P<.001). In the case of HADS-D, the scores were 4.7 (3.9) compared with 3.2 (3.1) (P<.004), respectively. CONCLUSIONS: Our findings indicate that it is necessary to assess the psychological state of patients with psoriasis, because psychological effects persist even in cases where the disease is almost totally controlled.
Asunto(s)
Psoriasis/psicología , Adaptación Psicológica , Adulto , Ansiedad/etiología , Estudios Transversales , Depresión/etiología , Emociones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Psoriasis/tratamiento farmacológico , Calidad de Vida , Autoimagen , Índice de Severidad de la Enfermedad , Factores Socioeconómicos , Encuestas y CuestionariosRESUMEN
INTRODUCTION AND OBJECTIVES: Biologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy. MATERIAL AND METHOD: We conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology. RESULTS: The characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects. CONCLUSIONS: No major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis.
Asunto(s)
Productos Biológicos/uso terapéutico , Inmunosupresores/uso terapéutico , Psoriasis/tratamiento farmacológico , Sistema de Registros , Adulto , Distribución por Edad , Anciano , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/uso terapéutico , Productos Biológicos/efectos adversos , Comorbilidad , Sustitución de Medicamentos , Utilización de Medicamentos , Femenino , Humanos , Inmunosupresores/efectos adversos , Masculino , Persona de Mediana Edad , Psoriasis/epidemiología , España/epidemiología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
No disponible
Asunto(s)
Humanos , Congresos como Asunto/organización & administración , Congresos como Asunto/normas , Congresos como Asunto , Psoriasis/epidemiología , Psoriasis/prevención & control , Enfermedades de la Piel/epidemiología , Enfermedades de la Piel/historia , Enfermedades de la Piel/prevención & controlRESUMEN
No disponible